Clinical Trial Network

Future Directions for Clinical Trial Network acting as Academic Contract Research Organisation

1. Background

The European Society of Anaesthesiology Clinical Trial Network has been initiated on 2010 at the request of the ESA Research Committee and approval by the ESA Board of Directors with  the  primary  aim  to  provide  an  infrastructure  for  Institutions,  clinicians  and  scientists allowing  to  work  across  borders  to  improve  the  care  of  patients  in  the  field  of Anaesthesiology,  Intensive  Care  Medicine,  Peri-Operative  Medicine,  Emergency  Medicine and Pain Medicine. International networks all over the world have demonstrated the  advantages  of  collaboration  to  address  and  answer  clinically  relevant  research  questions. Long-term collaborative relationships within research, education and clinical practice require dedicated resources and infrastructure enabling access to the entire clinical community. The aim of the ESA Clinical Trial Network (CTN) is to build such a collaborative network. Over the past 4 years, a group of highly dedicated physician-scientists across Europe have conducted studies. Already in 2011 the first observational clinical trials could  be  performed  with  more  than  500  centres,  who  contributed  to  the  great  success  of  the EUSOS study and the PERISCOPE study. The following years, ESA CTN selected the first paediatric multicentre audit of clinical anaesthetic practice in Europe, APRICOT: more than 250 centres participated and recruiting over 30,000 children. Currently NECTARINE, EPiMAP Obstetrics, PROBESE, MET-REPAIR, COMMAS are actively recruiting while other studies are getting ready for publication.  

2. Progressing with needs 

Entrusted by hundreds of hospitals, academic, and  government  organisations  worldwide, ESA CTN represents a powerful and rapidly growing alternative to study organisation and management for clinical research.  As a non-profit organisation, ESA provides a unique efficient, flexible, and low-cost way of managing different types of clinical studies. The ESA CTN Network has a proven record in conducting big clinical studies. A community of more than 6,000 clinicians make sure that the CTN studies evolve rapidly.  Data management and analysis is done in close collaboration with the steering committee of the trial and the ESA research unit in Brussels. It  has  become  clear  that  the  ESA  Research  CTN  Group  should  not  merely  focus  on supporting  observational  studies  but  also  consider  supporting  interventional  studies. Pharmaceutical industries with investigational study drugs or medical device in the field of Anaesthesia, Intensive  Care Medicine,  Peri-Operative Medicine, Emergency  Medicine and Pain  Medicine  could  also  gain  interest  in  collaborating  with  ESA  CTN.  ESA  CTN Coordination  &  Management  can  be  used  effectively  in  diverse  settings:    The  ESA  CTN includes  services  related  to  clinical  study  coordination;  study  management  and  allows flexibility and customisation.   


3.  The ESA CTN is focusing on three highly interrelated actions: 

  • Support  studies  identifying  relevant  research  questions  related  mainly  to  Anaesthesia,  Intensive Care Medicine, Peri-Operative Medicine, Emergency  Medicine  or  Pain  Medicine, but also to other specialties (nutrition, respiratory  diseases,  transfusion,  thrombosis,  cardiology,  etc.) when they  are  related  to anaesthesiology   
  • Foster  collaborations  between  ESA  members  of  various  countries  as  well  as  with other  organisations  to  improve  patient  outcome  and  anaesthesia  Intensive  Car Medicine, Peri-Operative Medicine,  Emergency  Medicine  or  Pain Medicine practice.
  • Enforce quality and Good clinical Practice in the study coordination support and data Management

 

4.  The ESA CTN Commitments

  1. ESA  is  a  Non-Profit  organisation:  all  benefits  will  support  actual  costs  or  be reinvested in Research Grants and educational activities. No benefits granted to ESA shareholder, etc. 
  2. Each Study Steering Committee should be independent from the Industry
  3. The Study selection Process should be transparent 
  4. The Centre selection Process should be transparent
  5. The Industry should be “ESA Partner” 
  6. The  Industry  and  ESA  CTN  roles  and  responsibilities  should  be  transparent:  A contract should clearly state that Industry role is Sponsor and ESA the ‘collaborator’ (insurance and liability) 
  7. The  deployment  of  ESA  CTN  as  A-CRO  will  be  progressive  and  adapt  ESA  Staff according to the rapid growing structure